Cutaneous Effects of Cryogen Spray Cooling - Full Text View

Sponsor:	Montana Compton
Collaborators:	Beckman Laser Institute University of California Irvine Candela Corporation
Information provided by (Responsible Party):	Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581568

Purpose

Researchers preliminary studies with epoxy skin phantoms have shown that liquid CO2 spray is effective to protect the epidermis during dermatologic laser therapy. This study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns of CSC in Fitzpatrick skin types I-VI.

However, the lower temperature induced by CO2 spray may tend to cause stronger cutaneous effects. It is researchers hypothesis that spurt durations of 80 ms or less will result in a very low incidence (less than 2%) of clinical skin effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type.

Condition	Intervention	Phase
Healthy	Other: CSC during laser treatment	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Cutaneous Effects of Cryogen Spray Cooling

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

low incidence of clinical skin effects in any skin type. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	53
Study Start Date:	January 2004
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: cooling spray cooling spray during laser treatment	Other: CSC during laser treatment CSC

Detailed Description:

Cryogen spray cooling (CSC) is a method to cool and thus, protect the epidermis which is used with dermatologic laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences.

CSC with Tetrafluoroethane has been incorporated into many Food and Drug Administration approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation. A millisecond cryogen spurt is applied to the skin surface immediately before laser exposure.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult 18 years and older

Exclusion Criteria:

Age <18
History of cold sensitivity
Inflammatory rash on the test site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581568

Locations

United States, California
Beckman Laser Institute Medical and Surgical clinic
Irvine, California, United States, 92612

Sponsors and Collaborators

Montana Compton

Beckman Laser Institute University of California Irvine

Candela Corporation

Investigators

Study Chair:

John S Nelson, M.D.,Ph.D

Beckman laser Institute

More Information

No publications provided

Responsible Party:	Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581568 History of Changes
Other Study ID Numbers:	CAN-44711, LAMMP
Study First Received:	December 19, 2007
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

protect the epidermis during skin laser treatment

ClinicalTrials.gov processed this record on February 12, 2012